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Senior RA Manager Medical Devices Software


  Bavaria,   Competitive

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  Regulatory Affairs    Permanent

Vacancy Details

My client, a Global Medical devices company are looking for a Senior RA Manager Medical Devices Software based in Bavaria.

A great opportunity to join a fast-growing company with a great portfolio of products and clients.

Senior RA Manager Medical Devices Software

Location: Bavaria

Salary: Competitive

Duration: Permanent

Job function:

  • Lead regulatory strategy for Medical Devices Software
  • Compilation of tech files
  • Implementing QMS to ISO 134585 or MDSAP
  • Close interaction with international Notified Bodies and Competent Authorities
  • Setting up risk management
  • Right SOPs for QMS
  • Being responsible for leading projects

To be considered you need to have.

  • Eligibility to work in Germany.
  • 5+ years’ experience in medical devices industry
  • 3+ years’ experience in Regulatory Affairs
  • Profound knowledge in 62304 and MDSW CE marking
  • 510(k) experience (desirable)
  • English mandatory
  • German (desirable)
  • 60601 experience (desirable)

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV and the best time for a call to to setup a confidential discussion about potential opportunities.

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

CLS offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

Catalyst Life Sciences

CLS are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets.

  • Pre-clinical Development & Safety
  • Clinical Development
  • Medical Affairs & Information
  • Regulatory Affairs
  • Pharmacovigilance/Drug Safety
  • Quality & Validation
  • Finance

My Linked In Profile

linkedin.com/in/cheikh-khoule

I personally specialise in recruiting QA, RA and validation professionals for roles across DACH so please do get in touch should you be considering new roles or looking to fill ones at your current company!

KEYWORDS

RA / regulatory / MDD / MDR / devices / 13485 / submission / regulatory / FDA / CFR / 21 / MDSAP / 62304 / project / manager / CE / marking / QMS / SOP / technical / files / documentation / Risk / medical / software

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Cheikh.Khoule

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